{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Scottsdale",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95709",
      "recalling_firm": "Orthoscan, Inc.",
      "address_1": "14555 N 82nd St",
      "address_2": "",
      "postal_code": "85260-2525",
      "voluntary_mandated": "FDA Mandated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. (including Puerto Rico).",
      "recall_number": "Z-0579-2025",
      "product_description": "Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system",
      "product_quantity": "50",
      "reason_for_recall": "Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.",
      "recall_initiation_date": "20240808",
      "center_classification_date": "20241202",
      "report_date": "20241211",
      "code_info": "UDI: EZIEZIEHMVISIONRFD3D1.  Serial Numbers:  21118, 21212, 22040, 22710, 22764, 23247, 23248, 23255, 23257, 23258, 23259, 23260, 23327, 23328, 23329, 23456, 23457, 23458, 23459, 23653, 23654, 23655, 23656, 23657, 23666, 23667, 23668, 23669, 23670, 23671, 23672, 23673, 23674, 23723, 23740, 23744, 23745, 23746, 23747, 23748, 23749, 23750, 23751, 23752, 23753, 23775, 23801, 23802, 23828, 23849.",
      "more_code_info": ""
    }
  ]
}